Intended Use Statement (US FDA): BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
BioSphere® Putty can be used as bone graft
replacement in the long bones and pelvis.
The moldable consistency of the Putty allows
it to be custom fit to the implant site. Once the defect is completely filled, the putty matches the bone void geometry.
Due to its firmness, the Putty can either be manually implanted, or inserted with forceps or other surgical instruments.
When mixed with autograft, BioSphere® Putty can be used as a bone graft extender in the posterolateral spine.
The Putty is specially designed to maintain its handling following mixing with autograft.
Following hardware placement, it can be isnerted with forceps and placed at the implant site
BioSphere® Putty can be shaped to conform to the bony anatomy and provides a custom fit around stabilization hardware.
*Images show BioSphere® Putty prior to combination with autograft. BioSphere® Putty must be mixed with autograft prior to use in the posterolateral spine.